Drug product
Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017
D-0556-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1040 cartons
- Official record key
drug-enforcement:D-0556-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: EC5911
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations